Persistent Asthma
Conditions
Brief summary
The primary objective of the study is to evaluate the long-term safety of fluticasone propionate (Fp) inhalation powder in 2 strengths and fluticasone propionate/salmeterol inhalation (FS) powder in 2 strengths when administered with the Teva multidose dry powder inhaler (MDPI) device over 26 weeks in patients with persistent asthma.
Detailed description
This was a stratified, randomized, open-label, active drug-controlled Phase 3 study. Patients who met all of the inclusion criteria and none of the exclusion criteria at the screening visit completed a 14 day (±2 days) pretreatment run in period. During the run-in period, patients continued using their current asthma medications (ie, inhaled corticosteroid and/or other controller therapies) except for their SABA, which was replaced by the sponsor-provided albuterol (salbutamol) hydrofluoroalkane (HFA) inhaler to be used as needed for symptomatic relief of asthma symptoms during the run in and treatment periods. Patients were assigned to inhaled corticosteroid (ICS) monotherapy or inhaled corticosteroid/long acting beta2 agonist (ICS/LABA) combination therapy and then to a mid- or high-treatment strength based on their current asthma maintenance therapy regimen. Patients in each strength of the ICS monotherapy cohort were randomly assigned in a 3:1 distribution to either the Fp MDPI or FLOVENT HFA treatment arm. Patients in each strength of the ICS/LABA combination cohort were randomly assigned in a 3:1 distribution to either the FS MDPI or ADVAIR DISKUS treatment arm. There was a total of 8 treatment arms following randomization.
Interventions
DRUGFp MDPI
Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate dispersed in a lactose monohydrate excipient. During the treatment period, participants were randomized to either 100 mcg or 200 mcg of Fp one inhalation twice a day for a total daily dose of 200 mcg or 400 mcg. Study drug was administered in the morning and in the evening.
DRUGFS MDPI
FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) and salmeterol xinafoate (Sx) dispersed in a lactose monohydrate excipient. During the treatment period, participants were randomized to either Fp/Sx MDPI 100/12.5 mcg or Fp/Sx MDPI 100/12.5 mcg twice a day for a total daily dose of 200/25 mcg or 400/25 mcg Fp/Sx. Study drug was administered in the morning and in the evening.
DRUGFLOVENT HFA
FLOVENT HFA is a hydrofluoroalkane (HFA) inhaler containing fluticasone propionate. During the treatment period, participants were randomized to either 110 mcg or 220 mcg of FLOVENT two puffs, twice a day for a total daily dose of 440 mcg or 880 mcg. Study drug was administered in the morning and in the evening.
DRUGADVAIR DISKUS
ADVAIR DISKUS contains a dry powder formulation of fluticasone propionate (Fp) and salmeterol xinafoate (Sx) in a lactose excipient. During the treatment period, participants were randomized to Fp 250 mcg/Sx 50 mcg or Fp 500 mcg/Sx 50 mcg one inhalation, twice a day for a total daily dose of 500/100 mcg or 1000/100 mcg. Study drug was administered in the morning and in the evening.
DRUGalbuterol/salbutamol HFA
A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Best pre-bronchodilator forced expiratory volume in 1 second (FEV1) of greater than 40% of their predicted normal value. 2. Patients must have a treatment regimen that includes a short-acting β2 agonist (SABA) (albuterol) for use as needed and either an inhaled corticosteroid (ICS) or an ICS/long-acting β2 agonist (LABA) as a preventative treatment for a minimum of 8 weeks before the SV. Patients currently taking low-dose ICS without LABA are not eligible for this study. Patients currently taking low-dose ICS/LABA may only be entered into the mid ICS strength. All patients must have been maintained on a stable dose of ICS or ICS/LABA for 4 weeks prior to the SV (or pre-SV if necessary) at 1 qualifying doses 3. To meet reversibility of disease criteria, the patient must demonstrate a ≥12% reversibility of FEV1 (and 200 mL for patients aged18 years and older) within 30 minutes following 4 inhalations of albuterol at the SV. Historic reversibility within the past 12 months of the SV may be used to meet this criterion. 4. Written informed consent/assent is obtained. For adult patients (aged 18 years and older, or as applicable per local regulations), the written informed consent form (ICF) must be signed and dated by the patient before conducting any study-related procedure. For minor patients (aged 12 to 17 years, or as applicable per local regulations), the written ICF must be signed and dated by the parent/legal guardian and the written assent form must be signed and dated by the patient (if applicable) before conducting any study-related procedure. Note: Age requirements are as specified by local regulations. 5. Outpatient \>= 12 years of age on the date of consent/assent. . 6. Asthma diagnosis: The patient has a diagnosis of asthma as defined by the National Institutes of Health (NIH). The asthma diagnosis has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in medication) for at least 30 days before providing informed consent. 7. The patient is able to perform acceptable and repeatable spirometry. 8. The patient is able to perform peak expiratory flow (PEF) with a handheld peak flow meter. 9. The patient is able to use a metered-dose inhaler (MDI) device without a spacer device and a MDPI device. 10. The patient is able to withhold (as judged by the investigator) his or her regimen of ICS or study drug, and rescue medication for at least 6 hours before the SV and before all treatment visits where spirometry is performed. 11. The patient/parent/legal guardian/caregiver is capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent/assent and being compliant with all study requirements. 12. SABAs: All patients must be able to replace their current SABA with albuterol/salbutamol HFA inhalation aerosol at the SV for use as needed for the duration of the study. 13. Female patients may not be pregnant, breastfeeding, or attempting to become pregnant. * -Other criteria may apply, please contact the investigator for more information
Exclusion criteria
1. The patient has a history of a life-threatening asthma exacerbation that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures. 2. The patient is pregnant or lactating, or plans to become pregnant during the study period or for 30 days after the study. 3. The patient has participated as a randomized patient in any investigational drug study within the 30 days preceding the SV (or prescreening visit, as applicable) or plans to participate in another investigational drug study at any time during this study. 4. The patient has previously participated in an Fp MDPI or FS MDPI study. 5. The patient has a known hypersensitivity to any corticosteroid, salmeterol, or any of the excipients in the study drug or rescue medication formulation (ie, lactose). 6. The patient has been treated with any known strong cytochrome P450 (CYP) 3A4 inhibitors (eg, azole antifungals, ritonavir, or clarithromycin) within 30 days before the SV or plans to be treated with any strong CYP3A4 inhibitor during the study. 7. The patient has been treated with any of the prohibited medications during the prescribed (per protocol) washout periods before the SV. 8. The patient currently smokes or has a smoking history of 10 pack-years or more (a pack-year is defined as smoking 1 pack of cigarettes/day for 1 year). The patient may not have used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco). 9. The patient has a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the SV. 10. The patient has a history of alcohol or drug abuse within 2 years preceding the SV. 11. The patient has had an asthma exacerbation requiring systemic corticosteroids within 30 days before the SV, or has had any hospitalization for asthma within 2 months before the SV. 12. Initiation or dose escalation of immunotherapy (administered by any route) is planned during the study period. However, patients who initiated immunotherapy 90 days or more before the SV and have been on a stable (maintenance) dose for 30 days or more before the SV may be considered for inclusion. 13. The patient has used immunosuppressive medications within 4 weeks before the SV. 14. The patient is unable to tolerate or unwilling to comply with the appropriate washout periods and withholding of all applicable medications. (Patients that require continuous treatment with β-blockers, monoamine oxidase inhibitors, tricyclic antidepressants, anticholinergics, and/or systemic corticosteroids are excluded). 15. The patient has untreated oral candidiasis at the SV. Patients with clinical visual evidence of oral candidiasis who agree to receive treatment and comply with appropriate medical monitoring may enter the study. 16. The patient has a history of a positive test for human immunodeficiency virus, active hepatitis B virus, or hepatitis C infection. 17. The patient is either an employee or an immediate relative of an employee of the clinical investigational center. 18. A member of the patient's household is participating in the study at the same time. However, after the enrolled patient completes or discontinues participation in the study, another patient from the same household may be screened. 19. The patient has a disease/condition that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study. * Other criteria may apply, please contact the investigator for more information Criteria for Randomization: Patients were randomized into the study if they met all of the following criteria: 1. The patient continued to be in general good health, meeting the entry criteria. 2. The patient continued to have a predose/pre-albuterol FEV1 at the randomization visit (RV) that was ≥40% of predicted normal. 3. The patient had no clinically significant abnormal laboratory test results or ECG findings at the screening visit. 4. The patient had no significant changes in asthma medications during run-in, excluding the albuterol/salbutamol HFA (90 mcg ex actuator) or equivalent used as rescue medication as supplied per protocol. 5. The patient did not have a upper respiratory tract infection (URI) or lower respiratory tract infection (LRI) during the run in period. Patients who developed a URI or LRI during the run in period could be discontinued from the study and allowed to re-screen 2 weeks after resolution of symptoms. 6. The patient had no asthma exacerbation during the run in period, defined as any worsening of asthma requiring any significant treatment other than rescue albuterol/salbutamol HFA (90 mcg ex actuator) or equivalent or the patient's run-in MDPI. This included requiring the use of systemic corticosteroids and/or emergency department (ED) visit or hospitalization or an increase in the patient's regularly prescribed nonsteroidal maintenance treatment. Urgent care/ED visits where the treatment was limited to a single dose of nebulized albuterol/salbutamol did not meet the criteria of an asthma exacerbation. 7. The patient had no clinical visual evidence (on oropharyngeal examination) of oropharyngeal candidiasis. 8. The patient did not experience an adverse event that would result in failure to continue to meet selection criteria. 9. The patient did not use any of the prohibited concomitant medications during the run in period. 10. The patient complied with completion of the daily diary, defined as follows: * completion of AM and PM asthma symptom scores on 4 or more of the 7 days immediately preceding the RV. * completion of rescue medication use (whether used or not) on 4 or more of the 7 days immediately preceding the RV. * completion of AM peak expiratory flow (PEF) measurements on 4 or more of the 7 days immediately preceding the RV. * recording of AM and PM asthma inhalation therapy use on 4 or more of the 7 days immediately preceding the RV.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | Day 1 to Week 26 of the Treatment Period | An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Positive Swab Test Results for Oral Candidiasis | Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, Endpoint | Oropharyngeal examinations for visual evidence of oral candidiasis were conducted at each visit by a qualified healthcare professional. Any visual evidence of oral candidiasis during the oropharyngeal exam was evaluated by obtaining and analyzing a swab of the suspect area. This outcomes indicates how many participants had positive swab test results. The total number of participants who had oropharyngeal exams at each timepoint are specified in the timepoint field. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation. Participants with a culture-positive infection could continue participation in the study on appropriate anti-infective therapy, provided this therapy was not prohibited by the protocol. |
| Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, Endpoint | Data represents participants with potentially clinically significant (PCS) vital sign values during the Treatment period. Significance criteria: * Systolic blood pressure - high: \>=180 and increase \>=20 mmHg * Systolic blood pressure - low: \<=90 and decrease \>=20 mmHg * Diastolic blood pressure - high: \>=105 and increase of \>=15 mmHg * Diastolic blood pressure - low: \<=50 and decrease of \>=15 mmHg * Pulse - high: \>=120 and increase of \>= 15 beats/minute from baseline * Pulse - low: \<=50 and decrease of \>=15 beats/minute |
| Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Screening (Day -14), Endpoint (week 26 if study was completed) | A 12 lead ECG was conducted at the screening visit and week 26 or the early termination visit. A qualified physician at a central diagnostic center was responsible for interpreting the ECG. The worst post-baseline finding for the participant is summarized. Endpoint refers to the last observation carried forward. |
| Analysis of 24-Hour Urine Cortisol Free Over the 26-Week Treatment Period | Baseline (Day 1, pre-treatment), Weeks 14 and 26 and early termination visit if applicable | Samples for 24-hour urine cortisol were collected at baseline (Day 1, pretreatment), and Weeks 14 and 26. For participants requiring early termination (ET), this evaluation was performed at the ET visit. For participants requiring ET for safety reasons, the visit was not delayed in order to collect the 24-hour urine cortisol. The analysis is based on a mixed model for repeated measures (MMRM) model with adjustment for visit, treatment, and a treatment\*visit interaction. The urine cortisol result is log transformed prior to analysis and the results are back transformed after modeling. An unstructured covariance matrix is used in the MMRM model. |
| Change From Baseline in Trough Forced Expiratory Volume in 1 Minute (FEV1) Over the 26-Week Treatment Period | Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, early termination visit if applicable | Spirometry measurements were obtained before the AM dose of study drug for the randomization visit (Day 1), at each of the treatment visits and at the early termination visit if applicable. At each visit where FEV1 was assessed, the highest acceptable results from each session were recorded. The analysis is based on a mixed model for repeated measures (MMRM) with adjustment for baseline FEV1, sex, age, (pooled) investigational center, visit, treatment, and treatment-by-visit. An unstructured covariance matrix is used in the MMRM model. |
Countries
United States
Participant flow
Recruitment details
Of the 1087 patients screened, 758 patients at 103 investigational centers in the US met entry criteria. 331 patients were not enrolled: 267 due to inclusion/exclusion criteria, 21 withdrew consent, 9 were lost to follow up, 4 had an adverse event, and 30 patients had reason of 'other' or missing.
Pre-assignment details
Participants in each strength of the ICS monotherapy cohort were randomly assigned in a 3:1 distribution to either the Fp MDPI or FLOVENT HFA treatment arm. Participants in each strength of the ICS/LABA combination cohort were randomly assigned in a 3:1 distribution to either the FS MDPI or ADVAIR DISKUS treatment arm.
Participants by arm
| Arm | Count |
|---|---|
| Fp MDPI 100 mcg Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication. | 127 |
| FLOVENT HFA 110 mcg Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication. | 42 |
| Fp MDPI 200 mcg Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication. | 126 |
| FLOVENT HFA 220 mcg Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication. | 41 |
| FS MDPI 100/12.5 mcg Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication. | 120 |
| ADVAIR DISKUS 250/50 mcg Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication. | 41 |
| FS MDPI 200/12.5 mcg Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication. | 133 |
| ADVAIR DISKUS 500/50 mcg Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication. | 44 |
| Total | 674 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Run-In Period (Pre-assignment) | Adverse Event | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Run-In Period (Pre-assignment) | Exclusion criteria met | 20 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Run-In Period (Pre-assignment) | Inclusion criteria not met | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Run-In Period (Pre-assignment) | Lost to Follow-up | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Run-In Period (Pre-assignment) | Other | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Run-In Period (Pre-assignment) | Randomization criteria not met | 23 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Run-In Period (Pre-assignment) | Withdrawal by Subject | 11 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period | Adverse Event | 0 | 2 | 1 | 1 | 1 | 3 | 2 | 0 | 1 |
| Treatment Period | Disease progression | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
| Treatment Period | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| Treatment Period | Lost to Follow-up | 0 | 3 | 1 | 3 | 1 | 2 | 1 | 2 | 2 |
| Treatment Period | Noncompliance | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 1 |
| Treatment Period | Other | 0 | 1 | 0 | 3 | 1 | 0 | 0 | 2 | 0 |
| Treatment Period | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Treatment Period | Withdrawal by Subject | 0 | 9 | 3 | 6 | 2 | 4 | 2 | 9 | 2 |
Baseline characteristics
| Characteristic | Fp MDPI 200 mcg | FLOVENT HFA 220 mcg | FS MDPI 100/12.5 mcg | ADVAIR DISKUS 250/50 mcg | FLOVENT HFA 110 mcg | FS MDPI 200/12.5 mcg | ADVAIR DISKUS 500/50 mcg | Total | Fp MDPI 100 mcg |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized Adolescents (12-17 years) | 16 Participants | 3 Participants | 13 Participants | 5 Participants | 7 Participants | 9 Participants | 1 Participants | 73 Participants | 19 Participants |
| Age, Customized Adults (18-64 years) | 96 Participants | 35 Participants | 94 Participants | 31 Participants | 32 Participants | 106 Participants | 41 Participants | 531 Participants | 96 Participants |
| Age, Customized Adults (65+ years) | 12 Participants | 3 Participants | 13 Participants | 5 Participants | 3 Participants | 18 Participants | 2 Participants | 68 Participants | 12 Participants |
| Age, Customized Missing | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| History of Smoking No tobacco use | 106 Participants | 36 Participants | 97 Participants | 34 Participants | 32 Participants | 109 Participants | 36 Participants | 551 Participants | 101 Participants |
| History of Smoking Prior smoker | 20 Participants | 5 Participants | 23 Participants | 7 Participants | 10 Participants | 24 Participants | 8 Participants | 123 Participants | 26 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 4 Participants | 0 Participants | 9 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 22 Participants | 5 Participants | 19 Participants | 9 Participants | 13 Participants | 31 Participants | 12 Participants | 127 Participants | 16 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 24 Participants | 8 Participants | 21 Participants | 5 Participants | 3 Participants | 20 Participants | 5 Participants | 95 Participants | 9 Participants |
| Race/Ethnicity, Customized Missing | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 100 Participants | 33 Participants | 99 Participants | 36 Participants | 39 Participants | 112 Participants | 39 Participants | 576 Participants | 118 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Pacific Islander | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 99 Participants | 36 Participants | 99 Participants | 32 Participants | 26 Participants | 95 Participants | 31 Participants | 528 Participants | 110 Participants |
| Sex/Gender, Customized Female | 78 Participants | 25 Participants | 84 Participants | 20 Participants | 26 Participants | 72 Participants | 23 Participants | 406 Participants | 78 Participants |
| Sex/Gender, Customized Male | 46 Participants | 16 Participants | 36 Participants | 21 Participants | 16 Participants | 61 Participants | 21 Participants | 266 Participants | 49 Participants |
| Sex/Gender, Customized Missing | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 44 | 0 / 42 | 0 / 41 | 0 / 120 | 0 / 133 | 0 / 127 | 0 / 125 |
| other Total, other adverse events | 22 / 41 | 23 / 44 | 24 / 42 | 25 / 41 | 70 / 120 | 68 / 133 | 65 / 127 | 55 / 125 |
| serious Total, serious adverse events | 2 / 41 | 3 / 44 | 2 / 42 | 3 / 41 | 6 / 120 | 13 / 133 | 7 / 127 | 8 / 125 |
Outcome results
Primary
Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Time frame: Day 1 to Week 26 of the Treatment Period
Population: Safety population which included all randomized participants who received at least 1 dose of randomized study drug.~The randomization allocation ratio of 3:1 (study drug: active comparator) should be taken into account when comparing treatment groups within treatment/strength cohorts
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fp MDPI 100 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE leading to withdrawal | 2 Participants |
| Fp MDPI 100 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 severe TEAE | 8 Participants |
| Fp MDPI 100 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 severe treatment-related TEAE | 0 Participants |
| Fp MDPI 100 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 treatment-related TEAE | 10 Participants |
| Fp MDPI 100 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 nonserious TEAE | 85 Participants |
| Fp MDPI 100 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE | 85 Participants |
| Fp MDPI 100 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 serious TEAE | 7 Participants |
| Fp MDPI 100 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE resulting in death | 0 Participants |
| FLOVENT HFA 110 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 treatment-related TEAE | 2 Participants |
| FLOVENT HFA 110 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 severe treatment-related TEAE | 0 Participants |
| FLOVENT HFA 110 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 severe TEAE | 3 Participants |
| FLOVENT HFA 110 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE | 29 Participants |
| FLOVENT HFA 110 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE resulting in death | 0 Participants |
| FLOVENT HFA 110 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 nonserious TEAE | 27 Participants |
| FLOVENT HFA 110 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE leading to withdrawal | 1 Participants |
| FLOVENT HFA 110 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 serious TEAE | 2 Participants |
| Fp MDPI 200 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 serious TEAE | 8 Participants |
| Fp MDPI 200 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE | 83 Participants |
| Fp MDPI 200 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 treatment-related TEAE | 6 Participants |
| Fp MDPI 200 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 severe treatment-related TEAE | 0 Participants |
| Fp MDPI 200 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 severe TEAE | 11 Participants |
| Fp MDPI 200 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 nonserious TEAE | 82 Participants |
| Fp MDPI 200 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE leading to withdrawal | 0 Participants |
| Fp MDPI 200 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE resulting in death | 0 Participants |
| FLOVENT HFA 220 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE | 29 Participants |
| FLOVENT HFA 220 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 severe treatment-related TEAE | 0 Participants |
| FLOVENT HFA 220 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE leading to withdrawal | 1 Participants |
| FLOVENT HFA 220 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE resulting in death | 0 Participants |
| FLOVENT HFA 220 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 nonserious TEAE | 29 Participants |
| FLOVENT HFA 220 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 serious TEAE | 3 Participants |
| FLOVENT HFA 220 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 treatment-related TEAE | 5 Participants |
| FLOVENT HFA 220 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 severe TEAE | 3 Participants |
| FS MDPI 100/12.5 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 nonserious TEAE | 91 Participants |
| FS MDPI 100/12.5 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 serious TEAE | 6 Participants |
| FS MDPI 100/12.5 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE resulting in death | 0 Participants |
| FS MDPI 100/12.5 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE leading to withdrawal | 3 Participants |
| FS MDPI 100/12.5 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 severe treatment-related TEAE | 0 Participants |
| FS MDPI 100/12.5 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE | 92 Participants |
| FS MDPI 100/12.5 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 severe TEAE | 8 Participants |
| FS MDPI 100/12.5 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 treatment-related TEAE | 9 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 serious TEAE | 2 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 treatment-related TEAE | 4 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 nonserious TEAE | 28 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE resulting in death | 0 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE | 29 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 severe TEAE | 1 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 severe treatment-related TEAE | 0 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE leading to withdrawal | 2 Participants |
| FS MDPI 200/12.5 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 severe treatment-related TEAE | 0 Participants |
| FS MDPI 200/12.5 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE | 86 Participants |
| FS MDPI 200/12.5 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE resulting in death | 0 Participants |
| FS MDPI 200/12.5 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 nonserious TEAE | 85 Participants |
| FS MDPI 200/12.5 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 serious TEAE | 13 Participants |
| FS MDPI 200/12.5 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 treatment-related TEAE | 11 Participants |
| FS MDPI 200/12.5 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 severe TEAE | 12 Participants |
| FS MDPI 200/12.5 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE leading to withdrawal | 0 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 severe treatment-related TEAE | 0 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE | 30 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 treatment-related TEAE | 8 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE resulting in death | 0 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 serious TEAE | 3 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 nonserious TEAE | 29 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 severe TEAE | 3 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | >=1 TEAE leading to withdrawal | 1 Participants |
Secondary
Analysis of 24-Hour Urine Cortisol Free Over the 26-Week Treatment Period
Samples for 24-hour urine cortisol were collected at baseline (Day 1, pretreatment), and Weeks 14 and 26. For participants requiring early termination (ET), this evaluation was performed at the ET visit. For participants requiring ET for safety reasons, the visit was not delayed in order to collect the 24-hour urine cortisol. The analysis is based on a mixed model for repeated measures (MMRM) model with adjustment for visit, treatment, and a treatment\*visit interaction. The urine cortisol result is log transformed prior to analysis and the results are back transformed after modeling. An unstructured covariance matrix is used in the MMRM model.
Time frame: Baseline (Day 1, pre-treatment), Weeks 14 and 26 and early termination visit if applicable
Population: A urine cortisol analysis subset of the safety population was defined that included participants whose urine samples did not have confounding factors at any visit that could affect the interpretation of the results.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fp MDPI 100 mcg | Analysis of 24-Hour Urine Cortisol Free Over the 26-Week Treatment Period | 18.45 mcg/24 hours |
| FLOVENT HFA 110 mcg | Analysis of 24-Hour Urine Cortisol Free Over the 26-Week Treatment Period | 13.94 mcg/24 hours |
| Fp MDPI 200 mcg | Analysis of 24-Hour Urine Cortisol Free Over the 26-Week Treatment Period | 14.14 mcg/24 hours |
| FLOVENT HFA 220 mcg | Analysis of 24-Hour Urine Cortisol Free Over the 26-Week Treatment Period | 17.50 mcg/24 hours |
| FS MDPI 100/12.5 mcg | Analysis of 24-Hour Urine Cortisol Free Over the 26-Week Treatment Period | 17.56 mcg/24 hours |
| ADVAIR DISKUS 250/50 mcg | Analysis of 24-Hour Urine Cortisol Free Over the 26-Week Treatment Period | 18.29 mcg/24 hours |
| FS MDPI 200/12.5 mcg | Analysis of 24-Hour Urine Cortisol Free Over the 26-Week Treatment Period | 13.02 mcg/24 hours |
| ADVAIR DISKUS 500/50 mcg | Analysis of 24-Hour Urine Cortisol Free Over the 26-Week Treatment Period | 15.42 mcg/24 hours |
Comparison: Mid-strength comparison90% CI: [1.02, 1.72]
Comparison: High-strength comparison90% CI: [0.63, 1.04]
Comparison: Mid-strength comparison90% CI: [0.75, 1.24]
Comparison: High-strength comparison90% CI: [0.67, 1.06]
Secondary
Change From Baseline in Trough Forced Expiratory Volume in 1 Minute (FEV1) Over the 26-Week Treatment Period
Spirometry measurements were obtained before the AM dose of study drug for the randomization visit (Day 1), at each of the treatment visits and at the early termination visit if applicable. At each visit where FEV1 was assessed, the highest acceptable results from each session were recorded. The analysis is based on a mixed model for repeated measures (MMRM) with adjustment for baseline FEV1, sex, age, (pooled) investigational center, visit, treatment, and treatment-by-visit. An unstructured covariance matrix is used in the MMRM model.
Time frame: Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, early termination visit if applicable
Population: The full analysis set (FAS) included all participants in the intent-to-treat (ITT) population who received at least 1 dose of study drug and had at least 1 post-baseline trough FEV1 assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fp MDPI 100 mcg | Change From Baseline in Trough Forced Expiratory Volume in 1 Minute (FEV1) Over the 26-Week Treatment Period | 0.062 liters | Standard Error 0.0243 |
| FLOVENT HFA 110 mcg | Change From Baseline in Trough Forced Expiratory Volume in 1 Minute (FEV1) Over the 26-Week Treatment Period | 0.053 liters | Standard Error 0.0415 |
| Fp MDPI 200 mcg | Change From Baseline in Trough Forced Expiratory Volume in 1 Minute (FEV1) Over the 26-Week Treatment Period | 0.077 liters | Standard Error 0.0246 |
| FLOVENT HFA 220 mcg | Change From Baseline in Trough Forced Expiratory Volume in 1 Minute (FEV1) Over the 26-Week Treatment Period | 0.090 liters | Standard Error 0.0415 |
| FS MDPI 100/12.5 mcg | Change From Baseline in Trough Forced Expiratory Volume in 1 Minute (FEV1) Over the 26-Week Treatment Period | 0.116 liters | Standard Error 0.0251 |
| ADVAIR DISKUS 250/50 mcg | Change From Baseline in Trough Forced Expiratory Volume in 1 Minute (FEV1) Over the 26-Week Treatment Period | 0.117 liters | Standard Error 0.0419 |
| FS MDPI 200/12.5 mcg | Change From Baseline in Trough Forced Expiratory Volume in 1 Minute (FEV1) Over the 26-Week Treatment Period | 0.100 liters | Standard Error 0.0235 |
| ADVAIR DISKUS 500/50 mcg | Change From Baseline in Trough Forced Expiratory Volume in 1 Minute (FEV1) Over the 26-Week Treatment Period | 0.041 liters | Standard Error 0.0399 |
Comparison: Mid-strength comparisonp-value: 0.845195% CI: [-0.084, 0.103]mixed model for repeated measures
Comparison: High-strength comparisonp-value: 0.787795% CI: [-0.107, 0.081]mixed model for repeated measures
Comparison: Mid-strength comparisonp-value: 0.996695% CI: [-0.095, 0.095]mixed model for repeated measures
Comparison: High-strength comparisonp-value: 0.205695% CI: [-0.032, 0.15]mixed model for repeated measures
Secondary
Participants With Positive Swab Test Results for Oral Candidiasis
Oropharyngeal examinations for visual evidence of oral candidiasis were conducted at each visit by a qualified healthcare professional. Any visual evidence of oral candidiasis during the oropharyngeal exam was evaluated by obtaining and analyzing a swab of the suspect area. This outcomes indicates how many participants had positive swab test results. The total number of participants who had oropharyngeal exams at each timepoint are specified in the timepoint field. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation. Participants with a culture-positive infection could continue participation in the study on appropriate anti-infective therapy, provided this therapy was not prohibited by the protocol.
Time frame: Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, Endpoint
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fp MDPI 100 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 18 (n=111, 37, 115, 38, 109, 38, 117, 40) | 1 Participants |
| Fp MDPI 100 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 26 (n=111, 35, 113, 36, 110, 36, 116, 38) | 1 Participants |
| Fp MDPI 100 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Endpoint (n=125, 42, 123, 41, 119, 40, 132, 44) | 1 Participants |
| Fp MDPI 100 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Baseline (n=127, 42, 124, 41, 120, 41, 133, 44) | 2 Participants |
| Fp MDPI 100 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 10 (n=119, 37, 118, 39, 115, 39, 120, 40) | 0 Participants |
| Fp MDPI 100 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 14 (n=116, 36, 115, 38, 113, 38, 120, 41) | 1 Participants |
| Fp MDPI 100 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 2 (n=123, 42, 123, 40, 117, 39, 131, 43) | 2 Participants |
| Fp MDPI 100 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 22 (n=110, 36, 113, 36, 110, 37, 116, 38) | 1 Participants |
| Fp MDPI 100 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 6 (n=119, 41, 119, 40, 115, 39, 125, 43) | 1 Participants |
| FLOVENT HFA 110 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 26 (n=111, 35, 113, 36, 110, 36, 116, 38) | 0 Participants |
| FLOVENT HFA 110 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 18 (n=111, 37, 115, 38, 109, 38, 117, 40) | 0 Participants |
| FLOVENT HFA 110 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 14 (n=116, 36, 115, 38, 113, 38, 120, 41) | 0 Participants |
| FLOVENT HFA 110 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Baseline (n=127, 42, 124, 41, 120, 41, 133, 44) | 0 Participants |
| FLOVENT HFA 110 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 10 (n=119, 37, 118, 39, 115, 39, 120, 40) | 0 Participants |
| FLOVENT HFA 110 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 2 (n=123, 42, 123, 40, 117, 39, 131, 43) | 0 Participants |
| FLOVENT HFA 110 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 6 (n=119, 41, 119, 40, 115, 39, 125, 43) | 0 Participants |
| FLOVENT HFA 110 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Endpoint (n=125, 42, 123, 41, 119, 40, 132, 44) | 0 Participants |
| FLOVENT HFA 110 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 22 (n=110, 36, 113, 36, 110, 37, 116, 38) | 0 Participants |
| Fp MDPI 200 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 2 (n=123, 42, 123, 40, 117, 39, 131, 43) | 1 Participants |
| Fp MDPI 200 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 22 (n=110, 36, 113, 36, 110, 37, 116, 38) | 1 Participants |
| Fp MDPI 200 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 10 (n=119, 37, 118, 39, 115, 39, 120, 40) | 1 Participants |
| Fp MDPI 200 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 18 (n=111, 37, 115, 38, 109, 38, 117, 40) | 1 Participants |
| Fp MDPI 200 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Baseline (n=127, 42, 124, 41, 120, 41, 133, 44) | 0 Participants |
| Fp MDPI 200 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 6 (n=119, 41, 119, 40, 115, 39, 125, 43) | 0 Participants |
| Fp MDPI 200 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 26 (n=111, 35, 113, 36, 110, 36, 116, 38) | 1 Participants |
| Fp MDPI 200 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 14 (n=116, 36, 115, 38, 113, 38, 120, 41) | 1 Participants |
| Fp MDPI 200 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Endpoint (n=125, 42, 123, 41, 119, 40, 132, 44) | 1 Participants |
| FLOVENT HFA 220 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Baseline (n=127, 42, 124, 41, 120, 41, 133, 44) | 0 Participants |
| FLOVENT HFA 220 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 2 (n=123, 42, 123, 40, 117, 39, 131, 43) | 0 Participants |
| FLOVENT HFA 220 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 10 (n=119, 37, 118, 39, 115, 39, 120, 40) | 1 Participants |
| FLOVENT HFA 220 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 26 (n=111, 35, 113, 36, 110, 36, 116, 38) | 1 Participants |
| FLOVENT HFA 220 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 14 (n=116, 36, 115, 38, 113, 38, 120, 41) | 1 Participants |
| FLOVENT HFA 220 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 6 (n=119, 41, 119, 40, 115, 39, 125, 43) | 0 Participants |
| FLOVENT HFA 220 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 18 (n=111, 37, 115, 38, 109, 38, 117, 40) | 1 Participants |
| FLOVENT HFA 220 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 22 (n=110, 36, 113, 36, 110, 37, 116, 38) | 1 Participants |
| FLOVENT HFA 220 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Endpoint (n=125, 42, 123, 41, 119, 40, 132, 44) | 1 Participants |
| FS MDPI 100/12.5 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 22 (n=110, 36, 113, 36, 110, 37, 116, 38) | 1 Participants |
| FS MDPI 100/12.5 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 6 (n=119, 41, 119, 40, 115, 39, 125, 43) | 1 Participants |
| FS MDPI 100/12.5 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 14 (n=116, 36, 115, 38, 113, 38, 120, 41) | 2 Participants |
| FS MDPI 100/12.5 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 18 (n=111, 37, 115, 38, 109, 38, 117, 40) | 0 Participants |
| FS MDPI 100/12.5 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Baseline (n=127, 42, 124, 41, 120, 41, 133, 44) | 0 Participants |
| FS MDPI 100/12.5 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 2 (n=123, 42, 123, 40, 117, 39, 131, 43) | 1 Participants |
| FS MDPI 100/12.5 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 10 (n=119, 37, 118, 39, 115, 39, 120, 40) | 1 Participants |
| FS MDPI 100/12.5 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 26 (n=111, 35, 113, 36, 110, 36, 116, 38) | 0 Participants |
| FS MDPI 100/12.5 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Endpoint (n=125, 42, 123, 41, 119, 40, 132, 44) | 0 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 26 (n=111, 35, 113, 36, 110, 36, 116, 38) | 1 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 6 (n=119, 41, 119, 40, 115, 39, 125, 43) | 2 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Endpoint (n=125, 42, 123, 41, 119, 40, 132, 44) | 1 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 22 (n=110, 36, 113, 36, 110, 37, 116, 38) | 0 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 2 (n=123, 42, 123, 40, 117, 39, 131, 43) | 0 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 14 (n=116, 36, 115, 38, 113, 38, 120, 41) | 0 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Baseline (n=127, 42, 124, 41, 120, 41, 133, 44) | 0 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 10 (n=119, 37, 118, 39, 115, 39, 120, 40) | 1 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 18 (n=111, 37, 115, 38, 109, 38, 117, 40) | 1 Participants |
| FS MDPI 200/12.5 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 6 (n=119, 41, 119, 40, 115, 39, 125, 43) | 1 Participants |
| FS MDPI 200/12.5 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 2 (n=123, 42, 123, 40, 117, 39, 131, 43) | 1 Participants |
| FS MDPI 200/12.5 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Endpoint (n=125, 42, 123, 41, 119, 40, 132, 44) | 0 Participants |
| FS MDPI 200/12.5 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 14 (n=116, 36, 115, 38, 113, 38, 120, 41) | 1 Participants |
| FS MDPI 200/12.5 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 18 (n=111, 37, 115, 38, 109, 38, 117, 40) | 0 Participants |
| FS MDPI 200/12.5 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 22 (n=110, 36, 113, 36, 110, 37, 116, 38) | 2 Participants |
| FS MDPI 200/12.5 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 10 (n=119, 37, 118, 39, 115, 39, 120, 40) | 0 Participants |
| FS MDPI 200/12.5 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 26 (n=111, 35, 113, 36, 110, 36, 116, 38) | 0 Participants |
| FS MDPI 200/12.5 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Baseline (n=127, 42, 124, 41, 120, 41, 133, 44) | 0 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 14 (n=116, 36, 115, 38, 113, 38, 120, 41) | 1 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 18 (n=111, 37, 115, 38, 109, 38, 117, 40) | 0 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Endpoint (n=125, 42, 123, 41, 119, 40, 132, 44) | 0 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 26 (n=111, 35, 113, 36, 110, 36, 116, 38) | 0 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 6 (n=119, 41, 119, 40, 115, 39, 125, 43) | 0 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Baseline (n=127, 42, 124, 41, 120, 41, 133, 44) | 0 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 22 (n=110, 36, 113, 36, 110, 37, 116, 38) | 2 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 10 (n=119, 37, 118, 39, 115, 39, 120, 40) | 1 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Positive Swab Test Results for Oral Candidiasis | Week 2 (n=123, 42, 123, 40, 117, 39, 131, 43) | 2 Participants |
Secondary
Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period
Data represents participants with potentially clinically significant (PCS) vital sign values during the Treatment period. Significance criteria: * Systolic blood pressure - high: \>=180 and increase \>=20 mmHg * Systolic blood pressure - low: \<=90 and decrease \>=20 mmHg * Diastolic blood pressure - high: \>=105 and increase of \>=15 mmHg * Diastolic blood pressure - low: \<=50 and decrease of \>=15 mmHg * Pulse - high: \>=120 and increase of \>= 15 beats/minute from baseline * Pulse - low: \<=50 and decrease of \>=15 beats/minute
Time frame: Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, Endpoint
Population: Safety population of participants with a baseline and postbaseline vital sign value.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fp MDPI 100 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Systolic blood pressure - high | 0 Participants |
| Fp MDPI 100 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Diastolic blood pressure - high | 1 Participants |
| Fp MDPI 100 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Systolic blood pressure - low | 1 Participants |
| Fp MDPI 100 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Pulse - high | 1 Participants |
| Fp MDPI 100 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Diastolic blood pressure - low | 1 Participants |
| Fp MDPI 100 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Pulse - low | 1 Participants |
| Fp MDPI 100 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | >=1 abnormality | 5 Participants |
| FLOVENT HFA 110 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Systolic blood pressure - low | 0 Participants |
| FLOVENT HFA 110 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Diastolic blood pressure - low | 0 Participants |
| FLOVENT HFA 110 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | >=1 abnormality | 0 Participants |
| FLOVENT HFA 110 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Pulse - low | 0 Participants |
| FLOVENT HFA 110 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Pulse - high | 0 Participants |
| FLOVENT HFA 110 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Systolic blood pressure - high | 0 Participants |
| FLOVENT HFA 110 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Diastolic blood pressure - high | 0 Participants |
| Fp MDPI 200 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Diastolic blood pressure - low | 0 Participants |
| Fp MDPI 200 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Diastolic blood pressure - high | 0 Participants |
| Fp MDPI 200 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | >=1 abnormality | 0 Participants |
| Fp MDPI 200 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Pulse - high | 0 Participants |
| Fp MDPI 200 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Systolic blood pressure - low | 0 Participants |
| Fp MDPI 200 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Pulse - low | 0 Participants |
| Fp MDPI 200 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Systolic blood pressure - high | 0 Participants |
| FLOVENT HFA 220 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Pulse - high | 0 Participants |
| FLOVENT HFA 220 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Pulse - low | 0 Participants |
| FLOVENT HFA 220 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Systolic blood pressure - low | 0 Participants |
| FLOVENT HFA 220 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Diastolic blood pressure - high | 0 Participants |
| FLOVENT HFA 220 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | >=1 abnormality | 1 Participants |
| FLOVENT HFA 220 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Diastolic blood pressure - low | 1 Participants |
| FLOVENT HFA 220 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Systolic blood pressure - high | 0 Participants |
| FS MDPI 100/12.5 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Pulse - low | 0 Participants |
| FS MDPI 100/12.5 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | >=1 abnormality | 2 Participants |
| FS MDPI 100/12.5 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Pulse - high | 0 Participants |
| FS MDPI 100/12.5 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Diastolic blood pressure - low | 1 Participants |
| FS MDPI 100/12.5 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Systolic blood pressure - high | 0 Participants |
| FS MDPI 100/12.5 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Systolic blood pressure - low | 1 Participants |
| FS MDPI 100/12.5 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Diastolic blood pressure - high | 0 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | >=1 abnormality | 0 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Diastolic blood pressure - low | 0 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Systolic blood pressure - low | 0 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Pulse - low | 0 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Systolic blood pressure - high | 0 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Pulse - high | 0 Participants |
| ADVAIR DISKUS 250/50 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Diastolic blood pressure - high | 0 Participants |
| FS MDPI 200/12.5 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | >=1 abnormality | 2 Participants |
| FS MDPI 200/12.5 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Systolic blood pressure - high | 0 Participants |
| FS MDPI 200/12.5 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Systolic blood pressure - low | 0 Participants |
| FS MDPI 200/12.5 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Diastolic blood pressure - high | 1 Participants |
| FS MDPI 200/12.5 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Diastolic blood pressure - low | 1 Participants |
| FS MDPI 200/12.5 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Pulse - high | 0 Participants |
| FS MDPI 200/12.5 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Pulse - low | 0 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Pulse - low | 0 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Pulse - high | 0 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Diastolic blood pressure - low | 0 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Diastolic blood pressure - high | 0 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Systolic blood pressure - low | 0 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | Systolic blood pressure - high | 0 Participants |
| ADVAIR DISKUS 500/50 mcg | Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period | >=1 abnormality | 0 Participants |
Secondary
Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings
A 12 lead ECG was conducted at the screening visit and week 26 or the early termination visit. A qualified physician at a central diagnostic center was responsible for interpreting the ECG. The worst post-baseline finding for the participant is summarized. Endpoint refers to the last observation carried forward.
Time frame: Screening (Day -14), Endpoint (week 26 if study was completed)
Population: Safety population of participants with both screening and endpoint ECGs
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fp MDPI 100 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline abnormal - Endpoint normal | 4 Participants |
| Fp MDPI 100 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline normal - Endpoint abnormal | 8 Participants |
| Fp MDPI 100 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline abnormal - Endpoint abnormal | 11 Participants |
| Fp MDPI 100 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline normal - Endpoint normal | 89 Participants |
| FLOVENT HFA 110 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline abnormal - Endpoint normal | 1 Participants |
| FLOVENT HFA 110 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline normal - Endpoint normal | 31 Participants |
| FLOVENT HFA 110 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline normal - Endpoint abnormal | 5 Participants |
| FLOVENT HFA 110 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline abnormal - Endpoint abnormal | 2 Participants |
| Fp MDPI 200 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline abnormal - Endpoint normal | 4 Participants |
| Fp MDPI 200 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline normal - Endpoint abnormal | 6 Participants |
| Fp MDPI 200 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline abnormal - Endpoint abnormal | 13 Participants |
| Fp MDPI 200 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline normal - Endpoint normal | 93 Participants |
| FLOVENT HFA 220 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline normal - Endpoint normal | 33 Participants |
| FLOVENT HFA 220 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline abnormal - Endpoint abnormal | 3 Participants |
| FLOVENT HFA 220 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline abnormal - Endpoint normal | 2 Participants |
| FLOVENT HFA 220 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline normal - Endpoint abnormal | 1 Participants |
| FS MDPI 100/12.5 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline abnormal - Endpoint abnormal | 5 Participants |
| FS MDPI 100/12.5 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline normal - Endpoint abnormal | 9 Participants |
| FS MDPI 100/12.5 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline abnormal - Endpoint normal | 12 Participants |
| FS MDPI 100/12.5 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline normal - Endpoint normal | 90 Participants |
| ADVAIR DISKUS 250/50 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline normal - Endpoint normal | 30 Participants |
| ADVAIR DISKUS 250/50 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline normal - Endpoint abnormal | 2 Participants |
| ADVAIR DISKUS 250/50 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline abnormal - Endpoint normal | 2 Participants |
| ADVAIR DISKUS 250/50 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline abnormal - Endpoint abnormal | 4 Participants |
| FS MDPI 200/12.5 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline normal - Endpoint normal | 101 Participants |
| FS MDPI 200/12.5 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline normal - Endpoint abnormal | 8 Participants |
| FS MDPI 200/12.5 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline abnormal - Endpoint normal | 9 Participants |
| FS MDPI 200/12.5 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline abnormal - Endpoint abnormal | 7 Participants |
| ADVAIR DISKUS 500/50 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline normal - Endpoint abnormal | 3 Participants |
| ADVAIR DISKUS 500/50 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline abnormal - Endpoint abnormal | 4 Participants |
| ADVAIR DISKUS 500/50 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline normal - Endpoint normal | 28 Participants |
| ADVAIR DISKUS 500/50 mcg | Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings | Baseline abnormal - Endpoint normal | 4 Participants |